# K233499: Sapphire NC ULTRA Coronary Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: OrbusNeich Medical (Shenzhen) Co., Ltd.
- Decided: Aug 16, 2024 after 290 days
- Product code: LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to P790017 (1980). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211807: Sapphire NC 24, OrbusNeich Medical (Shenzhen) Co., Ltd. (2021) Summary page 4.

## Indications for use
The Sapphire NC ULTRA Coronary Dilatation Catheter is indicated for: Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction. In-stent restenosis. Post-delivery expansion of balloon expandable coronary stents.

Source page: https://510kreport.com/device/K233499
Methodology: https://510kreport.com/methodology